Kornimate/medical-research-clean huggingface dataset:
nutritional prehabilitation program and cardiac surgery outcome in pediatrics

Conditions: Congenital Heart Disease

Summary: nutritional prehabilitation program and cardiac surgery outcome in pediatrics. a randomized controlled trial.

nutritional prehabilitation program and cardiac surgery in pediatrics. a randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

Eligibility criteria:
the study included all infants with chd, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition . infants received long-term nutritional prehabiliatation. those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded
the visual effect of an investigational artificial tear in the tear layer.

Conditions: Dry Eye Disease

Summary: the purpose of this study is to investigate how the addition of a new artificial tear product when applied to the tear layer affects contrast sensitivity and optical aberrations over time. we will also determine if there are any adverse effects associated with drop instillation.

artificial tears are applied to the eye to treat a variety of eye conditions. these conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. the artificial tears are used to alleviate the dry eye symptoms. the administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a decrease in contrast sensitivity.1 - 6 temporal changes in tear film structure (e.g., drying of the tear layer) can distort the optical wavefront as it passes through the tear layer and subsequently reduce contrast sensitivity.1 theoretically, any substance applied to the tear layer that alters its structure could affect contrast sensitivity. previous work in our lab has demonstrated that refresh liquigel when applied to the tear layer of non-contact and contact lens wearing subjects can decrease contrast sensitivity.4, 5, 7 in this study, we propose to examine the effects of a new investigational artificial tear on contrast sensitivity and optical aberrations for up to 30 minutes after administration into the tear layer of normal and dry eye subjects. a questionnaire will also be used to determine the opinions of the subjects concerning this new artificial tear.

Eligibility criteria:
inclusion criteria: * thirty subjects free from ocular pathology will be chosen. ten of the subjects will have a normal tear layer, ten will have a mild dry eye, and ten will have a moderate/severe dry eye. all subjects will be over the age of 18. best corrected visual acuities will be at least 20/25 on a standard snellen acuity chart at distance. exclusion criteria: * subjects will be excluded from this project if they have, or during the course of the experiment they develop, an allergy to the eye drops used in this project.

Keywords: contrast sensitivity
impact of verticalization on intracranial hemodynamics assessed in transcranial doppler at the acute phase of cerebral infarction

Conditions: Stroke

Summary: the management of patients with ischemic stroke or transient ischemic attack is based on the preservation of a brain area by maintaining sufficient intracranial hemodynamics (ih) and with rapid recanalization. the impact of the patient's position (supine or seated position) on the ih in the event of narrowing or occlusion of an artery is poorly assessed but may be of particular importance. variations in blood flow according to the positioning of the patient's body are measurable using a transcranial doppler. the main objective is to verify whether intracerebral hemodynamic changes during early verticalization after ischemic stroke or transient ischemic attack are more frequent in patients with carotid stenosis or occlusion compared to those without stenosis or occlusion.


Eligibility criteria:
inclusion criteria: * ischemic stroke (aic) or transient ischemic attack (ait) of the carotid artery * duration of symptoms less than 48 hours * absence of homolateral or downstream intracranial stenosis or occlusion m1 * lifting authorized by the referent clinician. * rankin's score before aic/ait ≤ 2 • for cases: * carotid stenosis of more than 50% nascet (north american symptomatic carotid endarterectomy trial) or an occlusion • for controls: * absence of carotid stenosis greater than 50% nascet (north american symptomatic carotid endarterectomy trial) or occlusion exclusion criteria: - disrupted vigilance secondary exclusion criteria: * absence of a homolateral temporal acoustic window at the lesion * impossibility to verticalize the patient

Keywords: verticalization doppler intracranial hemodynamic cerebral artery velocity
exercise tolerance and lower-limb muscle power in patients with chronic respiratory disease

Conditions: Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive

Summary: the aim of this study is to validate the six minute stepper test (6mst) and the 5-repetition chair lift test (5sts) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease. as the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6mst and 5sts in comparison with their respective gold standards.


Eligibility criteria:
inclusion criteria: * age 40 and over * with a diagnosis of chronic obstructive pulmonary disease (gold ii - iv) or pulmonary fibrosis (\>6 months). * able to understand and follow verbal instructions during tests * affiliated with a social security scheme * willing to participate in the study exclusion criteria: * have a neurological, cardiovascular or balance disorder that could impair test performance. * having undergone respiratory rehabilitation within the last year. * with unstable disease (recent exacerbation \< 4 weeks). * pregnant and/or breast-feeding women * patients under guardianship or curatorship

Keywords: six minutes stepper test (6mst) 5-times sit to stand test (5sts) chronic obstructive pulmonary disease (copd) pulmonary fibrosis
reduction of groin wound infections after vascular surgery by using an incision management system (ims)

Conditions: Infections

Summary: comparison of the prevena™ ims with the standard wound management method of sterile plaster in vascular surgery patients.

comparison of the prevena™ ims with the standard wound management method of sterile plaster in vascular surgery patients. the aim is to demonstrate that the application of the prevena™ ims significantly reduces the incidence of postoperative wound infections. the wound infections will be classified according to szilagyi. the treatment phase begins following vascular surgery with wound management using either the prevena™ ims or a standard wound dressing, depending on the group to which the patient was randomly assigned. it involves a minimum stay of 7 and maximum 10 days in hospital.

Eligibility criteria:
inclusion criteria: * vascular surgery via right or left inguinal approach * nicotine abuse (active or according to medical condition) * risk factors: 1. cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction) 2. metabolic disorders (diabetes mellitus type i type ii, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency * previous vascular surgery with inguinal approach * signed informed consent form * persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel exclusion criteria: * local skin infections (fungal infections, acne) * pregnant and breast-feeding women * simultaneous participation in another clinical trial * persons who have been committed to an institution by court or administrative order * persons in a dependency or employment relationship with the sponsor or investigator

Keywords: vascular surgery patients wound management
rhinoplasty scar comparison

Conditions: Surgical Incision; Nose Deformity

Summary: traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent skin sutures. these sutures create less inflammation and are thought to lead to improved final scar outcomes. however, permanent sutures require removal which creates pain and inconvenience for the patient. some surgeons use fast absorbing sutures that do not require removal. the difference in final scar outcome based on suture material used has not been well studied. this study will examine the final scar outcomes of rhinoplasty incisions sutured with traditional permanent suture compared to fast absorbing suture. if scar outcomes are similar between these groups as judged by the patients and blinded observers, rhinoplasty surgeons may be able to preferentially utilize absorbable sutures for incision closure and avoid the pain and inconvenience for the patient during suture removal


Eligibility criteria:
inclusion criteria •adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason with any of the study surgeons. exclusion criteria * patients undergoing rhinoplasty for cleft nasal deformity or nasal reconstruction related to cancer resection * patients with previous surgery that involved a columellar incision. patients with history of previous nasal surgery that did not involve an incision on the columella may be included * patients with known history of cutaneous disorder that affects scaring such as personal history of keloid formation, collagen vascular disease, or previous radiation to the surgical site * inability or unwillingness of subject to give informed consent
the efficacy of a dead sea mineral enriched body cream vs its carrier as an adjuvant treatment for psoriatic patients

Conditions: Psoriasis Vulgaris

Summary: this is a two-center study aimed to assess the efficacy of dead sea minerals in alleviating symptoms of psoriasis vulgaris, in 50 patients undergoing phototherapy. a bilateral left right comparison will be made, after using the study product and the placebo, for 8 weeks, twice daily, on each of the body sides (left right). in addition to the clinical evaluations, skin biochemistry will be studied using non-invasive techniques. the latter will be correlated with the clinical results of the patients. these will serve for future development of diagnostic assays and personalized therapies.


Eligibility criteria:
inclusion criteria: * having 2 symetrical (left right)moderate to severe chronic stable plaque type psoriasis for at least 6 months and candidates for phototherapy treatment exclusion criteria: * volunteers with a known allergy to one of the tested materials or to their ingredients. * treatment with medication such as anti-inflammatories, anti-histamines, corticosteroids, systemically or topically applied, unless stopped for 4 weeks prior to the trial in the case of systemic treatment and 2 weeks in the case of topical treatment. * volunteers in the process of diagnosis or treatment for cancer / kidney disease / liver disease * pregnant or lactating women

Keywords: modified pasi narrow band uvb phototherapy dead sea minerals skin auto-fluorescence skin wash samples
comparative measurement of microcirculation and other parameters with the vital usa vitaldetect™ in patients with diabetes mellitus type 1 and type 2 versus healthy participants

Conditions: Diabetes Mellitus

Summary: the purpose of this clinical study is to optimize the measurement algorithm of the vital usa vitaldetecttm in measuring the microcirculating blood flow. further optimization and finally the demonstration of the performance of the vitaldetecttm non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.

the study procedures will be the same for all three groups during the single visit. in all groups of participants, the vital usa vitaldetect™ will be individually introduced and assigned. during the experimental study visit, microcirculating blood flow (mbf), heart rate, and spo2 will be measured using the vital usa vitaldetect™ at 2 time points in between approx. 15 min. mbf will be measured in parallel by use of the lea medizintechnik o2c also using a finger on the same hand. the ysi glucose measurements will be employed to generate a robust algorithm for glucose measurements using the vitaldetect™. parallel measurements of the heart rate and the spo2 using a patient monitor (edan im8b) will be compared to the vital usa vitaldetect™ device readings. venous blood will be drawn from every subject to determine proinsulin, insulin and hba1c values.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetic or healthy subject (25 type 1, 25 type 2, 50 healthy subjects) * subjects who are able to complete informed consent form (by him/herself or by his/her guardian); * 18 years old and above; * anatomically suitable finger in discretion of the investigator exclusion criteria: * does not meet inclusion criteria; * any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos; * pregnancy; * nursing mothers; * any skin scratch(es), damage, over dry, long nails on the measured finger; * unsuitable finger with the device might be excluded if recognized during the trial; * medication containing nitrates
treatment of refractory excessive daytime sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (osa/hs) using nasal continuous positive airway pressure (ncpap) therapy (0249-015)

Conditions: Sleep Apnea, Obstructive; Hypopnea Syndrome; Excessive Daytime Sleepiness

Summary: the purpose of this study is to determine the safety and efficacy of mk0249 in treating refractory excessive daytime sleepiness (eds) in patients with obstructive sleep apnea/hypopnea syndrome (osa/hs) using nasal continuous positive airway pressure (ncpap) therapy.


Eligibility criteria:
inclusion criteria: * patient is male or female and is at least 18 years old and less than 65 years old * patient must have a diagnosis of obstructive sleep apnea/hypopnea syndrome * patient has been using ncpap treatment for at least 2 months prior to visit 1 * patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments * patient is willing to refrain from napping for the duration of the study exclusion criteria: * patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months * patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent * patient has had asthma-related visit to the emergency room or hospitalization within 6 months of visit 1 * patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study
a multi-site clinical evaluation of the aries norovirus assay

Conditions: Acute Gastroenteritis

Summary: the aries norovirus assay is a real-time pcr based qualitative in vitro diagnostic test for the direct detection of norovirus gi/gii rna from stool specimens obtained from symptomatic patients. the purpose of this study is to establish the diagnostic accuracy of aries norovirus assay.

the aries norovirus assay is a real-time polymerase chain reaction (pcr) based qualitative in vitro diagnostic test for the direct detection of norovirus gi/gii rna from stool specimens obtained from symptomatic patients. the objective is to establish the diagnostic accuracy of the aries norovirus assay through a multi-site, method comparison on prospectively collected leftover, stool specimens. diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement)

Eligibility criteria:
inclusion criteria: * the specimen is from a patient with symptoms of acute gastroenteritis. * the specimen is from a male or female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic. * the subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site. exclusion criteria: * the specimen is from an individual with known and documented non-infectious conditions such as ulcerative colitis, irritable bowel syndrome and/or crohn's disease * the specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
black women's wellness project

Conditions: Weight, Body; Knowledge, Attitudes, Practice

Summary: the proposed randomized controlled trial will evaluate an educational self-management intervention in 450 african american women and weight management. it will be the first to use a culturally tailored in-person and telephone approach to address all aspects of wellness and social determinants for african american women to achieve optimal long term wellness for both self and family.


Eligibility criteria:
inclusion criteria: * self-identified african american woman, aged 20-59 * bmi 27.5-57.4 * ability to walk unrestricted for \> 3 min * caretaker of a child -providing a meal at least 50% of days/week * caretaker of at least one child aged 5 -12 years * resides in jackson, saginaw, ypsilanti, lansing, detroit (all cities in michigan) * speaks english fluently exclusion criteria: * \<12 months postpartum * active pregnancy * prior or anticipated bariatric surgery * non-ambulatory * history of a severe cardiovascular event (including cerebrovascular accident or myocardial infarction) * severe mental illness, neurologic disease and/or cognitive impairment

Keywords: weight management obesity african american women
starr trans-anal resection versus vaginal rectocele repair using elevate: effects on defecatory function

Conditions: Rectocele

Summary: the primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.


Eligibility criteria:
inclusion criteria: * patient is not under any type of guardianship * patient has a rectocele \> 3 cm during defecography * patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ods score \> 10 * patient recieved information and signed the consent form exclusion criteria: * patient cannot read french * patient has an asymptomatic rectocele * patient with an enterocele at rest upon defecography, with opacification of the small bowel * patient with non-rehabilitated anorectal asynchrony (anism) * patient with anal incontinence, wexner score \> 7 * patient has a rectal lesion * patient has previously had rectal surgery including a colorectal anastomosis * patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles * patient has previously had pelvic radiotherapy * anal sphincter insufficiency detected by rectomanometry * megarectum detected by rectomanometry and defecography * granule transit anomaly: \> 70h * exteriorized rectal prolapse * rectovaginal fistule * intestinal inflammatory disease * anal stenosis * anal or rectal tumor * patient refuses to participate or refuses to sign consent * patient is enrolled in another study * contra indication for general or localized anesthesia * patient does not have social security coverage

Keywords: rectocele trans anal starr resection transvaginal repair
comparison of the effect of minimal invasive lens surgery and traditional cataract surgery

Conditions: Congenital Cataract

Summary: previously, the investigators have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. this prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.

patients with congenital cataract that requires surgical intervention are enrolled. then the participants are assigned to two groups: group i: the participants receive a minimal invasive lens surgery, while in group ii, the participants receive a traditional cataract surgery. a secondary intraocular lens implantation is performed when the patient is two years old for both group i and group ii. investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Eligibility criteria:
inclusion criteria: * age between 1 month and 24 months * uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag * informed consent signed by a parent or legal guardian exclusion criteria: * confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract * intraocular pressure \>21 mmhg * preterm birth (\<28 weeks) * presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy) * history of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family * history of ocular trauma * microcornea * persistent hyperplastic primary vitreous * rubella * lowe syndrome

Keywords: congenital cataract minimal invasive surgery secondary intraocular lens implantation